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there’s always enough pressure in the lungs to make sure the lungs don’t collapse, Hansen says. To keep the pressure from going to zero, the Children’s team tinkered with running the exhalation tube to different depths in the water, and a variety of different angles through which the bubbles are blown out. There’s still a lot left to be explained in terms of the math and physics of this approach, but essentially, the Children’s team thinks they may have hit upon the right formula by placing the tube at a deeper depth in the water and tilting the plastic tube upward in the water at a 135 degree angle, creating just the right balance of pressure to keep the lungs open, without pushing them too hard or flooding them with too much oxygen. The device has two simple dials, not a confusing bunch of bells and whistles like the standard machines, that allows a medical staffer to adjust breathing rate.
The Children’s machine can get its oxygen from a standard industrial tank, and can be made with commodity parts. Hansen estimates that it could be made for $500, making this far more affordable than anything sold to neonatal intensive care units in the U.S.
“I remember saying ‘guys, I think we can build this for a couple hundred bucks,'” Hansen recalls. “So they started building.”
Data to support the technique is still preliminary. The Children’s team ran an experiment with young, healthy rabbits that showed that its method could provide the same kind of lung support as a conventional ventilator. But researchers found that rabbits with severe lung impairment had 50 percent less stress on their lungs when they were on a Hansen Ventilator, compared with a conventional one. The findings were published in June in the journal Pediatric Research.
The next step, of course, is to show this can work in people. Children’s is mapping out its next steps in India, the world’s second most populous country, and which has one of the highest infant mortality rates in the world. Children’s wants to see if it can interest physicians there in a clinical trial, and designing the right kind of clinical trial that could demonstrate the tool is useful.
“All we have to do is prove that it’s just as good,” as existing ventilators, Hansen says, because then people would buy it because of the lower price.
Hansen didn’t offer a timeline for when such a trial might get underway. And since Seattle Children’s Hospital is a nonprofit, it will need a commercial partner at some point to manufacture, market, sell, and distribute this tool if it’s going to ever change the standard procedures for ventilating infants.
That least piece, the distribution/delivery piece of the puzzle, is often the hardest part of the problem to solve, as PATH CEO Chris Elias often likes to say in public talks. Hansen acknowledged it, saying it’s partly why Children’s has sought help from PATH, which specializes in making technological solutions practical in the developing world. Part of the challenge with infant mortality is even getting women to give birth in a hospital setting, which has a ventilator at the ready. And any safety concerns with the new approach could easily torpedo it.
Before I left, Hansen made it clear that he’s not content with just inventing something cool, getting his name on a few scientific papers, and polishing up the CV while he runs the day-to-day operations of a hospital. He wants this to get adopted in the developing world, and maybe even leading-edge hospitals in the U.S., although that will take more time to run trials that will pass scrutiny of the FDA.
“We’ve got a 100-fold advantage on value,” Hansen says. “The hard part will be diffusing it out. But this is so simple, you could have it in a village health clinic.”
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